Experience sharing on Dose Optimization in Oncology Development
Monday, Aug 4: 9:15 AM - 9:35 AM
Topic-Contributed Paper Session
Music City Center
As clinical trials continue to evolve in response to new regulatory standards, such as FDA's guidance on master protocol and dose optimization, there are significant challenges and opportunities for statisticians and data scientists. BeiGene has been at the forefront of adapting its strategies to align with these evolving guidelines. This presentation delves into our comprehensive approach to refining dose optimization processes in early-phase trials, emphasizing the collaboration between regulatory authorities and our internal teams. By sharing our experiences and lessons learned, we aim to highlight best practices and innovative strategies that enhance regulatory compliance while enhancing clinical trial efficiency. This discussion seeks to provide valuable insights that will drive the development of safer and more effective oncology therapies.
Dose optimization
Early-phase trials
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